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Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
Sponsor: Pharmazz, Inc.
Summary
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase-II Trial to Assess Safety, and Efficacy of Sovateltide in the Treatment of Hypoxic-ischemic Encephalopathy in Neonates
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-09-06
Completion Date
2026-12
Last Updated
2025-12-31
Healthy Volunteers
No
Interventions
Normal Saline along with standard treatment
Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm normal saline along with standard treatment will be given for active comparison.
Sovateltide along with standard treatment
Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm sovateltide along with standard treatment will be given for active comparison.
Locations (4)
Father Muller Medical College Hospital
Mangalore, Karnataka, India
Christian Medical College and Hospital
Ludhiana, Punjab, India
Niloufer Hospital
Hyderabad, Telangana, India
GSVM Medical College
Kanpur, Uttar Pradesh, India